Ross Laura, Hansen Dylan, Proudman Susanna, Walker Jennifer, Kumar Kimti, Stevens Wendy, Ferdowsi Nava, Sahhar Joanne, Ngian Gene-Siew, Apostolopoulos Diane, Host Lauren V, Morrisroe Kathleen, Major Gabor, Baron Murray, Nikpour Mandana
The University of Melbourne, Melbourne, and St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
Arthritis Care Res (Hoboken). 2025 Feb;77(2):251-256. doi: 10.1002/acr.25427. Epub 2024 Oct 9.
Physician global assessments (PhyGAs) are variably applied in systemic sclerosis (SSc) clinical trials. The comparability of different PhyGA results is unknown. We sought to assess the comparability of results from three different PhyGA instruments simultaneously applied in the Australian Scleroderma Cohort Study (ASCS).
Using data from 1,965 ASCS participants, we assessed the correlation between results of three PhyGA assessments: (1) overall health, (2) activity, and (3) damage. We evaluated the concordance of change in each PhyGA between study visits. Ordered logistic regression analysis was used to evaluate the clinical associations of each PhyGA.
The absolute scores of each PhyGA were strongly correlated at individual study visits. Concordant changes of the PhyGA scores occurred between 50% of study visits. Only patient-reported breathlessness was associated with all three PhyGA scores (overall health: odds ratio [OR] 1.67, P < 0.01; activity: OR 1.44, P < 0.01; damage: OR 1.32, P < 0.01). Changes in physician-assessed activity scores were also associated with patient-reported worsening skin disease (OR 1.25, P = 0.03) and fecal incontinence (OR 1.23, P = 0.01), whereas damage scores were associated with respiratory disease (pulmonary arterial hypertension: OR 1.25, P = 0.03; chronic obstructive pulmonary disease: OR 1.37, P = 0.04), as well as skin scores (OR 1.02, P < 0.01) and fecal incontinence (OR 1.21, P = 0.02).
PhyGAs of overall health, activity, and damage are each associated with different SSc features, and changes in different PhyGA scores are discordant 50% of the time. Our findings suggest results of variably worded PhyGAs are not directly interchangeable and support the development of a standardized PhyGA.
医师整体评估（PhyGAs）在系统性硬化症（SSc）临床试验中的应用方式各不相同。不同PhyGA结果的可比性尚不清楚。我们试图评估在澳大利亚硬皮病队列研究（ASCS）中同时应用的三种不同PhyGA工具的结果的可比性。
利用1965名ASCS参与者的数据，我们评估了三种PhyGA评估结果之间的相关性：（1）整体健康状况，（2）活动情况，以及（3）损伤情况。我们评估了每次研究访视期间每种PhyGA变化的一致性。采用有序逻辑回归分析来评估每种PhyGA的临床相关性。
在各个研究访视中，每种PhyGA的绝对分数都高度相关。50%的研究访视期间出现了PhyGA分数的一致变化。仅患者报告的呼吸急促与所有三种PhyGA分数相关（整体健康状况：比值比[OR]1.67，P<0.01；活动情况：OR 1.44，P<0.01；损伤情况：OR 1.32，P<0.01）。医师评估的活动分数变化也与患者报告的皮肤病加重（OR 1.25，P = 0.03）和大便失禁（OR 1.23，P = 0.01）相关，而损伤分数与呼吸系统疾病（肺动脉高压：OR 1.25，P = 0.03；慢性阻塞性肺疾病：OR 1.37，P = 0.04）以及皮肤分数（OR 1.02，P<0.01）和大便失禁（OR 1.21，P = 0.02）相关。
整体健康状况、活动情况和损伤情况的PhyGAs分别与不同的SSc特征相关，并且不同PhyGA分数的变化在50%的时间内不一致。我们的研究结果表明，措辞不同的PhyGAs结果不能直接互换，并支持开发标准化的PhyGA。
